Prosthesis for implanting around a body duct such as the urethra and method of treating urinary incontinence

ABSTRACT

Prosthesis consisting of a mesh material impregnated with an antibiotic, antiseptic, antispore medication or a combination of these which surrounds a conduit leading to the skin, such as the urethra, and having an end portion thereof embedded in a waterrepellent substance which protrudes from the end of the conduit and the surface of the skin and a cap therefor.

[451 Mar. 7, 1972 United States Patent Keshin [54] PROSTIHESIS FOR IMPLANTING 3,503,400 3/1970 Osthagen et al....................128/349 R FOREIGN PATENTS OR APPLICATIONS AROUND A BODY DUCT SUCH AS THE URETHRA AND METHOD OF TREATING URINARY INCONTINENCE [72] Inventor:

Jesse G. Keshin, 175 Crary Avenue, OTHER PUBLICATIONS The Use of an Inlying Plastic Conduit for Ch ronic Peritoneal Irrigation by J. P. Merrill et a1., Transactions Amer. Society for Artifical Internal Organs, Vol. VIII, 1962, pages 252- 255 Mount Vernon, N.Y. 10550 [22] Filed: July 23, 1969 [211 App]. No.: 844,071

Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks l28/DIG. 25 Attorney-Lackenbach 8L Lackenbach .A6lf 1/00, A6If 5/44 128/ I [52] U.S.CI. 128/283, 128/349 R,

[57] ABSTRACT Prosthesis consisting of a mesh material impregnated antibiotic, antiseptic, antispore medication or a com [58] Field of Search...............3/1; 283, 334, 348-351,

128/DIG. 25

with an bination of these which surrounds a conduit leading to the skin, such as g an end portion thereof embedded in a llent substance which protrudes from the end of the .m m a J h w d e m m i d wm mm. m m m tWC 3 Mm c s 5: mm n A wzmm m T m h h s ems e m Ill n w 1 6 w 333 kin and a cap therefor.

5 Claims, 5 Drawing Figures PROSTIIFSIS FOR IMPLANTING AROUND A BODY DUCT SUCK-I AS THE URETHRA AND METHOD OF TREATING URINARY INCONTINENCE This invention relates, generally, to medical prosthesis and, more particularly, to prosthesis applied to a conduit leading to the skin, such as a urethra.

The prosthesis of the present invention may comprise a tube, an end portion of which comprises a material into which tissue will grow and another end portion of which comprises a water-repellent substance. The portion into which the tissue will grow may be implanted around a tubal structure which protrudes to the skin, such as a urethra which, prior to implantation, must be freed from the surrounding tissue. The portion protruding beyond the urethra may be water-repellent and nonporous and the protruding end of the tub may be plugged by a solid plug or cap. The portion of the tube surrounding the urethra may be fixed in place by sutures so that when this tissue heals the tube will be permanently fixed and will be watertight. Control of urination can be accomplished by plugging or unplugging the protruding tube.

Having in mind the foregoing, it is a primary object of the present invention to provide a prosthesis which comprises one portion into which tissue will grow and another portion into which tissue will not grow.

Another primary object of the present invention, in addition to the foregoing object, is the provision of such a prosthesis in the form of a tube having one portion non-reactive to tissue and another portion which is water-repellent.

Yet another primary object of the present invention, in addition to each of the foregoing objects, is the provision of such a tube for implantation around a tubular structure, such as a urethra so that the portion protruding beyond the urethra will be water-repellent.

Yet still another primary object of the present invention, in addition to each of the foregoing objects, is the provision of such a tube which may be readily fixed in place, as by means of sutures and which when the surrounding tissue heals will be permanently fixed and will be watertight.

Another and yet a still further primary object of the present invention, in addition to each of the foregoing objects, is the provision of novel methods and apparatus for the treatment of urinary incontinence.

Yet another and still further primary object of the present invention, in addition to each of the foregoing objects, is the provision of novel prosthesis having one portion which is adapted for implantation under the skin of a patient fabricated of a porous material into which tissue will grow and a second portion adapted to protrude beyond the skin or a membrane surface fabricated of material which is nonporous and waterrepellent.

Still further, it is yet another primary object of the present invention, in addition to each of the foregoing objects, is to provide novel and improved methods and apparatus providing permanent prosthesis around any tubal structure which has a connection with the skin to prevent and control leakage and fluid flow through the structure such as urethra or in connection with colostomy, ileo-bladder procedures, and the like.

Yet still further, it is a primary object of the present invention, in addition to each of the foregoing objects, to provide novel and improved prosthesis comprising mesh material impregnated with antibiotic, antiseptic, antispore medication or a combination of these which surrounds a tubular structure, such as the urethra, and having a portion imbedded in a waterrepellent substance which protrudes from the end of the tubal structure and the surrounding skin or membrane, and which may be capped to preclude leakage therethrough.

Yet another primary object of the present invention, in addition to each of the foregoing objects, is the provision of a tubular device which can be readily attached to any tubular bodily structure and which is economical to manufacture and which is safe, durable and effective in use.

The invention resides in the combination, construction, arrangement and the disposition of the various component parts and elements incorporated in improved prosthesis constructed in accordance with the principles of this invention and in the methods of utilization thereof. The preset invention will be better understood and objects and important features other than those specifically enumerated above will become apparent when consideration is given to the following details and description, which when taken in conjunction with the annexed drawing describes, discloses, illustrates and shows a preferred embodiment or modification of the present invention and what is presently considered and believed to be the best mode of practicing the principles thereof. Other embodiments or modifications may be suggested to those having the benefit of the teachings herein, and such other embodiments or modifications are intended to be reserved especially as they fall within the scope and the spirit of the subjoined claims.

IN THE DRAWING FIG. 1 is a sketch of a urethra opening prior to the performance of any surgical procedure;

FIG. 2 is a sketch, similar to FIG. 1, of the urethra opening illustrating the manner in which an incision may be utilized to free the urethra from the surrounding tissue;

FIG. 3 is a sketch similar to the preceding figures showing a prosthesis positioned extending from the end of the urethra and the surface of the surrounding skin in accordance with the principles of the present invention;

FIG. 4 is a cross-sectional sketch illustrating the appropriate portion of a reclining female body having a prosthesis implanted and extending from the urethra in accordance with the present invention; and

FIG. 5 is an enlarged crosssectional view taken along the line 5-5 of FIG. 4, showing the construction of the prosthesis, in detail.

With reference now to the drawing, and particularly to FIGS. 3 and 5 thereof, there is shown and illustrated a novel prosthesis constructed in accordance with the principles of the present invention and designated generally by the reference character 10 which may comprise a generally tubular portion 12 adapted for the implantation of the body of a patient and a cap portion 14 adapted to close the tubular portion 12 to retain bodily fluids therewithin.

The tubular portion 12 may, for example, comprise a tubular mesh material impregnated with antibiotic, antiseptic, antispore medication or a combination of these and may comprise a substance which is nonreactive with the patients tissues and into which tissue will grow and is designated, in the drawing, by the reference character 16. The portion of the tubular prosthesis 12 which is adapted to project outwardly of the patients skin is preferably water-repellent and may comprise, for example, an extension of the tubular mesh material 16 provided with a single or double coating 18 of water-repellent and nonporous material which, preferably is also flexible or resilient. The cap 14 may be of substantially any desired construction and may, for example, comprise a shouldered plug of water-repellent, nonporous and flexible or resilient material, similar to that utilized for the coating 18.

The mesh material 16 may be fabricated to have a wide mesh and of substantially any knitted, woven, crocheted or braided synthetic or natural fibers that are nonabsorbable and compatible with the human body. For example, and without limitation, materials that may be suitable are silk, cotton, tantalum or precious metal gauze, rubbers, silicones, silastic, latex, butyl rubber polymer or plastics such as Vinyon-N (a resin manufactured by the Carbide and Carbon Corporation by copolymerizing vinyl chloride and acrylonitrile), nylon (a polyamide resin made by polymerization of the hexamethylene diamine salt adipic acid), Orlon (a synthetic fiber made by the E. I. du Pont de Nemours & Co., from polyacrylonitrile), Dacron (a synthetic fiber made by the E. I.

Company), Kel-F (polyflurotrichloroethylene), polyolefins such as polyethylene and polypropylene, urethanes, and the like.

The water-repellent and nonporous portion 18 may be produced by coating with any of the above or may be produced by fusing the fibers to form an integral article. Various adhesives may be used for this purpose and the Versamids (proprietary name for a series of polyamide resins produced by the condensation of poly carboxylic acids with polyamines) are one suitable type of adhesive, particularly for use with Dacron fibers. The fusing step, when the foregoing polyamide resin is employed, can be accomplished by simply curing the heat-setting adhesive. Ultrasonic technique may also be employed to fuse the fiber and polyethylene teraphthalate, for example, is known to be sealable by this technique. Straightforward heat-sealing techniques, utilizing direct or radiant heating may also be utilized to fuse the fibers.

With more particular reference now to FIG. 1, 2, 3 and 4, and as heretofore pointed out, the prosthesis of the present invention may be utilized in conjunction with substantially any tubular structure at the location where the structure reaches the skin. For example, the prosthesis of the present invention is particularly suited, for use in controlling urinary incontinence by implanting in contrast with the urethra of a female to treat incontinence and may be implanted, as follows:

In FIG. 1 there is illustrated a urethra as it would normally appear at the patients skin. Preparatory to implanting the prosthesis, an incision may be made as illustrated in FIG. 2 encircling the urethra and freeing the urethra from the surrounding skin. Then, the tubular mesh portion 16 of the prosthesis may be implanted into the incision so as to surround the end portion of the urethra with the coated portion 18 of the prosthesis adjacent the end portion of the urethra and projecting outwardly thereof and outwardly of the surface of the surrounding skin or membrane. Hence, it may be readily seen that with the present prosthesis, there is no need to insert any objects, catheters, or the like, into the urethra itself; the prosthesis surrounds the urethra and is not inserted within it.

As heretofore pointed out, the prosthesis consists of a tube, part of which is composed of a material into which tissue will grow, such as the mesh material 16 which is inserted into the incision and surrounding the tubular structure, such as the urethra. The portion 16 into which the tissue will grow may be fixed in place, as by sutures utilizing either nonabsorbable or absorbable sutures. When the tissue surrounding the implantation heals, the tube will be permanently fixed and will be watertight.

The projecting portion 18 of the prosthesis is, as heretofore pointed out, nonreactive, water-repellent and nonporous, as by being provided with the coating 18. The end of the tube may be plugged by the cap or plug 14 and control of urination can then be accomplished by plugging or unplugging the protruding tube.

It is to be expressly understood, however, that while the invention has been specifically set forth as applied to a prosthesis for urinary incontinence, particularly in women, the present invention is equally applicable to prosthesis of substantially any tubular structure having an outlet at or near the skin or a membrane. Moreover, while the present prosthesis has been specifically disclosed in conjunction with a solid plug or cap for controlling fluid flow thereto, substantially any other desired flow control means may be similarly utilized.

While the invention has been described, disclosed, illustrated and shown in terms of an embodiment or modification which it has assumed in practice, the scope of the invention should not be deemed to be limited by the precise embodiment or modification herein described, disclosed, illustrated or shown, such other embodiments or modifications as may be suggested to those having the benefit of the teachings herein being intended to be reserved especially if they fall within the scope and breadth of the claims here appended.

What is claimed is: l. A prosthesis for implantation in a generally circular inclsion closely encircling the end portion of a duct which normally terminates at and is joined with epidermal tissue comprising a bodily flexible elongated open-ended tubular member fabricated of a material which is nonreactive, nonabsorbable and compatible with bodily tissues with one end portion of said tubular member having an inside diameter selected to be'only slightly larger than the outside diameter of a duct to which it is to be secured so that such duct may be closely fit therewithin, said one end portion being provided with a plurality of circumferential wide-mesh openings extending entirely radially therethrough of a size so as to be sufficiently porous to permit fibrous tissue to grow easily in-' wardly through said one end portion to knit together with said duct and'retain said member in position therebetween, the other end portion of said tubular member being water-repellent and nonporous to retain fluids from such duct therewithin.

2. Prosthesis defined in claim 1 comprising a tubular fibrous mesh extending throughout substantially the entire longitudinal extent of said member and defining alone said one end portion and a water-repellent and nonporous coating extending substantially entirely over a longitudinally extensive portion of said mesh to define therewith said other end portion.

3. Prosthesis defined in claim 2 together with a solid waterproof removable closure closing said other end for precluding the flow of bodily fluids therethrough and removable to permit the passage of bodily fluids therethrough.

4. Method of treating urinary incontinence comprising, at least the steps of, freeing the end portion of the urethra of a patient from the surrounding skin, positioning a prosthesis comprising a bodily flexible tubular member, one end of which comprises a nonreactive material into which tissue can grow and the other end of which comprises a water-repellent, nonporous material with said one end portion thereof disposed within the incision and surrounding the end portion of the urethra and with the other end portion thereof protruding generally axially of the end of the urethra and from the surface of the surrounding skin; permitting of the tissue to grow into said one end; and selectively plugging and unplugging said other end portion of the prosthesis to control urination.

5. Method defined in claim 4 further comprising, at least the additional step of, suturing said one end portion of said prosthesis in position during implantation. 

2. Prosthesis defined in claim 1 comprising a tubular fibrous mesh extending throughout substantially the entire longitudinal extent of said member and defining alone said one end portion and a water-repellent and nonporous coating extending substantially entirely over a longitudinally extensive portion of said mesh to define therewith said other end portion.
 3. Prosthesis defined in claim 2 together with a solid waterproof removable closure closing said other end for precluding the flow of bodily fluids therethrough and removable to permit the passage of bodily fluids therethrough.
 4. Method of treating urinary incontinence comprising, at least the steps of, freeing the end portion of the urethra of a patient from the surrounding skin, positioning a prosthesis comprising a bodily flexible tubular member, one end of which comprises a nonreactive material into which tissue can grow and the other end of which comprises a water-repellent, nonporous material with said one end portion thereof disposed within the incision and surrounding the end portion of the urethra and with the other end portion thereof protruding generally axially of the end of the urethra and from the surface of the surrounding skin; permitting of the tissue to grow into said one end; and selectively plugging and unplugging said other end portion of the prosthesis to control urinAtion.
 5. Method defined in claim 4 further comprising, at least the additional step of, suturing said one end portion of said prosthesis in position during implantation. 